URL of this page: https://medlineplus.gov/druginfo/meds/a601148.html

Hydromorphone Injection

pronounced as (hye droe mor' fone)


[Posted 08/31/2016]

AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice

ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication, available at: http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.

FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication, available at: http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.

FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.

BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.

RECOMMENDATION: Health care professionalsshould limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

[Posted 03/22/2016]

AUDIENCE: Family Practice, Psychiatry, Pain Management, Nursing, Endocrinology

ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.

BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief (see List of Opioid Medicines in the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm). However, opioids also carry serious risks, including of misuse and abuse, addiction, overdose, and death.

Prescription opioids are divided into two main categories – immediate-release (IR) products, usually intended for use every 4 to 6 hours; and extended release/long acting (ER/LA) products, intended to be taken once or twice a day, depending on the individual product and patient.

See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for additional information, including a listing of opioids, serotonergic medicines, and a data summary.


Serotonin syndrome:

Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected.

Adrenal insufficiency:

Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off of the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if treatment with corticosteroids can be discontinued.

Decreased sex hormone levels:

Health care professionals should conduct laboratory evaluation in patients presenting with such signs or symptoms.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.


Hydromorphone injection is available as a regular strength solution (Dilaudid) and a concentrated solution (Dilaudid-HP) that contains more hydromorphone in each milliliter of solution. Your doctor should only prescribe the concentrated solution if you are opioid tolerant (have been treated with certain doses of narcotic medications for at least 1 week, allowing your body to adjust to this type of medication). The concentrated solution may cause serious side effects or death if it is used by a person who is not opioid tolerant. Be sure that you know which hydromorphone solution your doctor has prescribed, and always check to be sure you are receiving the correct medication.

Hydromorphone injection may be habit-forming and may cause slowed or stopped breathing or death if it is overused. Do not use more of it or use it more often than prescribed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse hydromorphone injection if you have or have ever had any of these conditions.

Do not allow anyone else to use your medication. Store hydromorphone injection in a safe place so that no one else can use it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.

Drinking alcohol or using street drugs during your treatment with hydromorphone injection increases the risk that you will experience serious, life-threatening side effects. Talk to your doctor about the risks of drinking alcohol or using street drugs during your treatment.

Taking certain other medications during your treatment with hydromorphone injection may increase the risk that you will experience serious, life-threatening side effects. Tell your doctor if you are taking or plan to take any of the following medications: other narcotic pain medications; medications for anxiety, seizures, mental illness, or nausea; muscle relaxants; sedatives; sleeping pills; or tranquilizers.

Why is this medication prescribed?

Hydromorphone injection is used to relieve pain. Hydromorphone injection is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

How should this medicine be used?

Hydromorphone injection comes as a solution (liquid) to inject under the skin, into a vein, or into a muscle. It is usually injected once every 2 to 3 hours as needed. Use hydromorphone injection exactly as directed.

Your doctor may adjust your dose of hydromorphone injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with hydromorphone injection.

If you have used hydromorphone injection for longer than a few days, do not stop using it suddenly. If you suddenly stop using hydromorphone injection, you may experience withdrawal symptoms including restlessness; teary eyes; runny nose; yawning; sweating; chills; muscle, back or joint pain; widening of the pupils; irritability; anxiety; weakness; stomach cramps; difficulty falling asleep or staying asleep; nausea; loss of appetite; vomiting; diarrhea; fast breathing; or fast heartbeat. Your doctor will probably decrease your dose gradually.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using hydromorphone injection,

  • tell your doctor and pharmacist if you are allergic to hydromorphone injection, any other medications, sulfites, latex, or any of the ingredients in hydromorphone injection solution. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: buprenorphine (Buprenex, Butrans, in Bunavail, in Suboxone); butorphanol; ipratropium (in Combivent); medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems; and pentazocine (Talwin). Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past 2 weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have asthma, slowed breathing, a blockage in your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use hydromorphone injection.
  • tell your doctor if you have or have ever had a head injury or any condition that caused damage to your brain; any condition that increases the pressure in your brain; kyphoscoliosis (curving of the spine that may cause breathing problems); low blood pressure; hypothyroidism (condition in which the thyroid gland produces less hormone than normal); lung disease such as chronic obstructive pulmonary disease (a group of diseases that affect the lungs and airways); Addison's disease (condition in which the adrenal gland produces less hormone than normal); seizures; delirium tremens (severe withdrawal symptoms that may occur in people who drank large amounts of alcohol over time and have stopped drinking); urethral stricture (blockage of the tube that allows urine to leave the body); an enlarged prostate (a male reproductive gland); or gallbladder, pancreas, liver, or kidney disease.
  • tell your doctor if you are pregnant or plan to become pregnant. If you take hydromorphone regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

  • tell your doctor if you are breast-feeding.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using hydromorphone injection.
  • you should know that hydromorphone injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that hydromorphone injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you are using hydromorphone injection on a regular schedule, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What side effects can this medication cause?

Hydromorphone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  1. nausea
  2. vomiting
  3. constipation
  4. dry mouth
  5. lightheadedness
  6. dizziness
  7. drowsiness
  8. sweating
  9. flushing
  10. itching
  11. mood changes

Some side effects can be serious. If you experience any of these symptoms, stop taking hydromorphone injection and call your doctor immediately or get emergency medical treatment:

  1. slowed or stopped breathing
  2. rash
  3. hives
  4. swelling of the eyes, face, lips, tongue, mouth, or throat
  5. difficulty breathing or swallowing
  6. hoarseness
  7. seizures
  8. fainting

Hydromorphone injection may cause other side effects. Call your doctor if you have any unusual problems while you are using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly. Throw away any medication that is outdated or no longer needed. Talk to your health care provider about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  1. slowed or stopped breathing
  2. sleepiness
  3. coma (loss of consciousness for a period of time)
  4. muscle weakness
  5. cold, clammy skin
  6. narrowing or widening of the pupils (dark circle in the middle of the eye)
  7. slowed or stopped heartbeat
  8. dizziness
  9. fainting
  10. snoring

What other information should I know?

Keep all appointments with your doctor.

This prescription is not refillable. If you continue to have pain after you finish the hydromorphone injection, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Dilaudid®
  • Dilaudid-HP®

Other names

  • dihydromorphinone
Last Revised - 09/15/2016